The current invention relates to an assembly method for a catheter device having a septum for blood control. In particular, the invention relates to a method and system whereby a catheter device is assembled such that the introducer needle is positioned within the catheter without causing damage to the septum of the catheter device.
Catheters are commonly used for a variety of infusion therapies. For example, catheters are used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition into a patient, withdrawing blood from a patient, as well as monitoring various parameters of the patient's vascular system.
Catheters are commonly introduced into the vasculature of a patient as part of an intravenous catheter assembly. The catheter assembly generally includes a catheter adapter, which supports the catheter, the catheter adapter being coupled to a needle hub which supports an introducer needle. The introducer needle is extended and positioned within the catheter such that a beveled portion of the needle is exposed beyond a tip of the catheter. The beveled portion of the needle is used to pierce the skin of the patient to provide an opening whereby to insert the needle in the vasculature of the patient. Following insertion and placement of the catheter, the introducer needle is removed from the catheter thereby providing intravenous access to the patient.
For some catheter devices, a septum is additionally placed within the catheter adapter so as to limit or control the passage of fluids through the catheter assembly. For example, following insertion of the catheter into a patient, blood from the patient will flow through the catheter and into the catheter adapter. By placing a septum within the catheter adapter, the septum acts as a barrier to prevent or control blood flow through the catheter adapter. Upon removal of the introducer needle from the catheter, the septum may also act to remove excess blood from the outer surface of the needle.
For some catheter devices, a septum actuator is further placed within the catheter adapter, whereby a user may advance the actuator through the septum to enable fluid to bypass the septum. The septum actuator may include a probe-like structure having a front end for piercing or otherwise bypassing the septum, and a tail end whereby the user contacts and advances the actuator through the septum. In some catheter devices, the septum actuator is positioned within a rearward portion of the catheter adapter prior to insertion of the catheter. Following insertion of the catheter and removal of the introducer needle, the septum actuator is advanced through the septum thereby providing fluid communication between the rearward portion of the catheter adapter and the vasculature of the patient.
Prior to using the catheter device, the various components of the device are assembled so as to provide a functional device. The method by which the catheter device is assembled is selected to correctly position the various components while preventing the occurrence of damage or misalignment of the components in the assembled device. Additionally, the assembly method is selected to provide high throughput and quality control.
Accordingly, there is a need in the art for assembly methods and systems that provide high throughput and highly reproducible catheter devices incorporating various components. Furthermore, there is a need in the art to provide a efficient assembly method that reduces or prevents damage or misalignment of the various components in an assembly catheter device. Such a method and system is disclosed herein.